# FDA recall Z-1948-2025

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2025-03-24.

## Product

Brand Name: Solana¿ Bordetella Complete Assay  Product Name: Solana Bordetella kit  Model/Catalog Number: M308  Software Version: not applicable  Product Description: One sales unit (kit) contains materials for 48 tests.    One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes.  Component: No, not a component

## Reason for recall

It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

## Distribution

Please see the attached list "Consignee List_CL2025-120."  Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary.     One (1) Distributor was affected.  The other four(4) Distributors were sent the notification for information only.  QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).

## Key facts

- **Recall number:** Z-1948-2025
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-24
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1948-2025

## Citation

> AI Analytics. FDA recall Z-1948-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1948-2025. Source: US FDA. Licensed CC0.

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